HIGHLIGHTS
July 28 - Aug. 1, 2013
2013 AACC Clinical Lab Expo, Houston
Booth: 4458
Houston, Texas
United States
Sep. 28 - Oct. 2, 2013
2013 RAPS Annual Conference & Exhibition
Booth: tbd
Boston, Massachusetts
United Sates
Contact MDSS
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany
Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633
Click here to
contact us
Schiffgraben 41
30175 Hannover
Germany
Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633
Click here to
contact us
National Registration Spain
National Registration of In-Vitro Diagnostic Devices and Medical Devices with the Spanish Authority
Any physical or legal entity has to notify the Spanish Authority "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" prior to bringing Medical Devices of risk class IIa, IIb or III on the Spanish market or putting them into service in Spain for the first time (chapter 6, article 22, Royal Decree (RD) 1591/2009).
In-Vitro Diagnostic Device and Medical Device manufacturers who are located outside the EU are obliged to designate an Authorized Representative (article 24, RD 1591/2009).
In-Vitro Diagnostic Device and Medical Device manufacturers who are located outside the EU are obliged to designate an Authorized Representative (article 24, RD 1591/2009).
The Spanish national registration will be done electronically, by the Authorized Representative, via an online databank established by the Spanish Authority.
Appoint MDSS to perform the Spanish National Registration on your behalf
Our service includes:- Advice regarding the data requirements and review of the required technical documentation of Medical Devices and In-Vitro Diagnostic Devices
- Multilingual staff with profound regulatory experience
- Insertion of the relevant Medical Device and In-Vitro Diagnostic Device product information into the online database of the Spanish Authority
- Communication in Spanish Language with the Competent Authority
For further information please contact us:
Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover
Germany
Phone: +49 511 6262 8630
Fax: +49 511 62628630
Or Click here for our Contact Form
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